Active substanceLidocaine + Cetylpyridinium chlorideLidocaine + Cetylpyridinium chloride
Dosage form: & nbspgel dental
Composition:

1 g of gel contains:

Active substances: lidocaine hydrochloride in terms of 100% anhydrous substance - 3.3 mg, cetylpyridinium chloride in terms of 100% anhydrous substance - 1.0 mg;

Excipients: Sorbitol liquid non-crystallizable, xylitol, ethyl alcohol 96% glycerol, gietelloza (hydroxyethyl cellulose), Macrogol glitserilgidroksistearat (macrogol 40 glitserilgidroksistearat), lauromacrogol 600 (macrogol lauryl ether), macrogol 300, sodium saccharin, levomenthol, flavor, chamomile, Caramel E 150a , sodium citrate, citric acid, purified water.

Description:

Gel from light yellow to yellow with a brownish hue. A weak characteristic odor is allowed.

Pharmacotherapeutic group:Local anesthetic
ATX: & nbsp

R.02   Drugs for the treatment of throat diseases

Pharmacodynamics:

Mechanism of action

Preparation Baby Baby is an analgesic for applying on the mucous membrane of the oral cavity. Lidocaine has a local anesthetic effect when applied to the mucosa. Cetylpyridinium chloride has antiseptic properties.

Pharmacokinetics:

Suction

Lidocaine is rapidly absorbed from the mucous membrane.

Cetylpyridinium chloride is poorly absorbed through the mucosa of the oral cavity.

Distribution

Lidocaine binds to blood plasma proteins, including a1acid glycoprotein (ACHA). The degree of binding varies and is about 66%. The binding of lidocaine to plasma proteins depends on the concentrations of lidocaine and ACHA. Any change in the concentration of ACHA can greatly affect the concentration of lidocaine in the blood plasma.

Metabolism

Lidocaine is largely metabolized in the liver. Metabolism in the liver is rapid. About 90% of the lidocaine received is dealkylated to form monoethylglycinexylidide and glycinexylidide.

Excretion

Metabolites of lidocaine are excreted by the kidneys, while less than 10% is excreted as unchanged lidocaine.

Indications:

Drug Babe is prescribed for teething.

The Baby Baby helps to ease the pain with teething and reduces irritation of the gums.

The Baby Baby drug also has a weak antiseptic effect.
Contraindications:

- Hypersensitivity to lidocaine, other amide anesthetics, cetylpyridinium or any other component of the drug;

- rare hereditary intolerance to fructose;

- children's age up to 3 months.

Pregnancy and lactation:

Not studied.

Dosing and Administration:

For application to the mucous membrane.

Children

The Lident Baby preparation is intended for children from the age of 3 months.

A small amount of gel (about 7.5 mm) is applied to the tip of a clean finger and gently rubbed into the inflamed portion of the baby's gum. If necessary, the gel can be applied repeatedly at intervals of 20 minutes, but not more than 6 times a day.

Patients with impaired renal function

Not studied.

Patients with impaired hepatic function

Not studied.

Side effects:

When using Lident Baby in accordance with these instructions for use, undesirable reactions are unlikely. However, single cases of hypersensitivity to lidocaine following local injections in adults and children over the age of 12 have been reported.

Hypersensitivity, which occurred in these cases, was expressed in the form localized edema,accompanied by minor difficulty breathing or generalized rash.

A slight amount of chamomile in the fragrance can cause allergic reactions. In people predisposed to atopy, hypersensitivity to substances contained in chamomile, manifests itself in the form of difficulty breathing. Anaphylactic reactions have been reported with the intake of herbal tea containing chamomile. In persons with hypersensitivity, a positive skin reaction can occur with the use of drugs containing chamomile.

In case of any undesirable reactions, it is necessary to stop using Lident Baby and consult a doctor for advice.

Overdose:

Symptoms

As a result of excessive use of Lident Baby, a decrease in pharyngeal sensitivity may occur with a concomitant effect on swallowing. This effect was registered in an adult who, when rinsing his throat, swallowed 5 ml of a 2% solution of lidocaine hydrochloride (equivalent to 100 mg lidocaine). If we compare the body surface area to the surface area of ​​the pharynx of the child at the age of 3 months, this dose will be equivalent to 5.4 g of Lident Baby.Even with improper or excessive use of Lident Baby, it is unlikely to achieve those large amounts of lidocaine hydrochloride or cetylpyridinium chloride that could cause clinically significant toxic effects.

Treatment

In case of an overdose, stop using Lident Baby and consult a doctor.

Interaction:

There is no data on the interaction of Lident Baby with other drugs.

If other medications are needed, consult a doctor.

Special instructions:

Do not exceed recommended doses.

Effect on the ability to drive transp. cf. and fur:

Not studied.

Form release / dosage:

Dental gel 0.33% + 0.1%.

Packaging:

By 5 or 10 g in an aluminum tube. Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LP-004280
Date of registration:02.05.2017
Expiration Date:02.05.2022
The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
Manufacturer: & nbsp
Information update date: & nbsp23.05.2017
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